510(k) K261381 · OUR Sacroiliac Joint Fixation
TiLink-L SI Joint Fusion System
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Aug 24, 2026 |
| Received | Apr 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261381
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.